TPLC - Total Product Life Cycle

• Device: prosthesis, breast, noninflatable, internal, silicone gel-filled
• Definition: Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
• Product Code: FTR
• Regulation Number: 878.3540
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
14	10	21	8	10	9

MDR Year	MDR Reports	MDR Events
2019	21378	21378
2020	24290	24290
2021	23355	23355
2022	30810	30810
2023	29098	29101
2024	20064	20064

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	66256	66256
Adverse Event Without Identified Device or Use Problem	38596	38596
Device Appears to Trigger Rejection	30884	30887
Patient-Device Incompatibility	14064	14064
Patient Device Interaction Problem	3705	3705
Migration	3253	3253
Gel Leak	1967	1967
Appropriate Term/Code Not Available	1191	1191
No Apparent Adverse Event	620	620
Off-Label Use	281	281
Device Handling Problem	275	275
Fluid/Blood Leak	269	269
Material Deformation	203	203
Break	201	201
Material Discolored	190	190
Malposition of Device	179	179
Use of Device Problem	178	178
Insufficient Information	124	124
Improper or Incorrect Procedure or Method	109	109
Device Contamination with Chemical or Other Material	90	90
Nonstandard Device	82	82
Difficult to Open or Remove Packaging Material	81	81
Defective Device	55	55
Leak/Splash	50	50
Migration or Expulsion of Device	49	49
Device Dislodged or Dislocated	45	45
Material Protrusion/Extrusion	45	45
Air/Gas in Device	44	44
Delivered as Unsterile Product	35	35
Positioning Failure	34	34
Biocompatibility	34	34
Device Contaminated During Manufacture or Shipping	34	34
Short Fill	27	27
Microbial Contamination of Device	26	26
Material Invagination	23	26
Material Integrity Problem	23	23
Positioning Problem	23	23
Unsealed Device Packaging	20	20
Inadequacy of Device Shape and/or Size	19	19
Peeled/Delaminated	18	18
Deflation Problem	18	18
Unintended Deflation	17	17
Device Damaged Prior to Use	15	15
Shipping Damage or Problem	14	14
Contamination	14	14
Biofilm coating in Device	13	13
Product Quality Problem	12	12
Defective Component	9	9
Loss of or Failure to Bond	8	8
Structural Problem	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Capsular Contracture	74102	74105
Failure of Implant	34700	34700
Deformity/ Disfigurement	13879	13879
No Code Available	12502	12503
Seroma	8030	8030
Pain	3686	3687
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3165	3165
Unspecified Infection	2152	2152
Breast Discomfort/Pain	1934	1934
Swollen Lymph Nodes/Glands	1894	1894
No Clinical Signs, Symptoms or Conditions	1795	1795
Granuloma	1760	1760
Wrinkling	1270	1270
Rupture	1268	1268
Fatigue	1093	1094
Breast Mass	1064	1064
Insufficient Information	922	922
Autoimmune Reaction	870	870
Swollen Lymph Nodes	828	828
Local Reaction	819	819
Lymphoma	788	788
Autoimmune Disorder	786	787
Hematoma	696	696
Anxiety	632	632
Post Operative Wound Infection	614	614
Inflammation	612	615
Headache	591	592
Arthralgia	578	578
Hair Loss	552	553
Cyst(s)	489	489
Wound Dehiscence	456	456
Rash	425	426
Depression	417	417
Weight Changes	417	417
Necrosis	392	392
Memory Loss/Impairment	391	392
Impaired Healing	385	385
Cancer	369	369
Cognitive Changes	350	350
Paresthesia	348	348
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)	342	342
Sleep Dysfunction	330	330
Injury	311	311
Anaplastic Large Cell Lymphoma	305	305
Hypersensitivity/Allergic reaction	291	291
Crushing Injury	286	286
Neurological Deficit/Dysfunction	267	267
Dyspnea	264	264
Numbness	260	260
Skin Inflammation/ Irritation	257	257

Recalls
Manufacturer		Recall Class	Date Posted
1	Allergan PLC	III	Dec-18-2019
2	Allergan PLC	I	Sep-11-2019